(412 days)
The SoftLight Q-switched Nd: YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is designed to deliver a nominal output of 1.0 Joule per pulse at a fixed operating wavelength of 1064 nm in a collimated beam. The pulse repetition rate is 1, 2, 5 or 10 pulses per second (Hz) and single shot. The Q-Switched output pulses are nominally 6-20 nsec in duration. The output beam is delivered through a 7 mirror articulated arm and beam delivery handpiece which allows an easy access to the treatment site. The collimated laser beam gives a fixed spot size of between 6 and 7 mm at the treatment site. This laser can be set to deliver fluences of between approximately 1 to 3.5 J/cm2. The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled key pad on the control panel of the laser. The accessory topical lotion is a suspension of carbon powder, in a base of Light Mineral Oil, NF.
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is indicated for use in combination with a ThermoLase-supplied topical lotion for laser skin resurfacing and for removing or lightening unwanted facial or body hair. The provided document focuses mainly on the device description and regulatory approval process, with limited details on specific acceptance criteria and a detailed study report. Based on the available information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | "Clinical trials involving human subjects followed for 8 months showed no safety issues." |
| Efficacy for Laser Skin Resurfacing | "The treatment was shown to remove or ablate skin epidermis in the treatment area." |
| Efficacy for Hair Removal/Lightening | (Not explicitly stated in terms of acceptance criteria or performance in the provided text, but is an indicated use. Substantial equivalence to a predicate device for this use is mentioned.) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical trials involving human subjects" but does not specify the exact sample size used for these trials.
The data provenance is clinical trials involving human subjects, implying prospective data collection. The country of origin is not explicitly stated, but the company (ThermoLase Corporation) is located in San Diego, California, suggesting the studies likely occurred in the USA or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Details regarding ground truth establishment, including the number and qualifications of experts (e.g., dermatologists, plastic surgeons), are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in the document. The device is a laser system, not an AI diagnostic tool, so such a study would not be applicable in this context.
6. Standalone (Algorithm Only) Performance Study
This concept is not applicable as the device is a laser system, not a standalone algorithm. Its performance is intrinsically linked to the physical intervention of the laser and the topical lotion with human application.
7. The Type of Ground Truth Used
Based on the performance statements, the ground truth appears to be based on direct observation of clinical outcomes. For skin resurfacing, it's "removal or ablation of skin epidermis," which would likely be assessed visually or histologically by medical professionals. For safety, it's the absence of "safety issues."
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of laser device development, as it's not an AI/machine learning model in the modern sense. The "clinical trials involving human subjects" would serve as the primary data for demonstrating safety and efficacy, analogous to a validation set. The specific sample size for these trials is not provided.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" is not directly applicable. However, the ground truth for the clinical trials (the evidence demonstrating safety and efficacy) was established through clinical observation and assessment by medical professionals over an 8-month follow-up period. This would involve evaluations of skin changes (ablation/removal of epidermis) and the reporting/monitoring of adverse events.
{0}------------------------------------------------
MAY 1 3 1998
ThermoLase Corporation 510(k) Premarket Notification
Laser Skin Resurfacing
510(k) Summary ThermoLase SoftLight™ Laser
Submitter:
Trade name:
Common name:
Classification name:
Legally marketed predicate:
Device description:
Indications for Use:
Technological characteristics:
Laser
The ThermoLase SoftLight Q-Switched Nd: YAG Laser is designed to deliver a nominal output of 1.0 Joule per pulse at a fixed operating wavelength of 1064 nm in a collimated beam. The pulse repetition rate is 1, 2, 5 or 10 pulses per second
Revision May 7, 1998
K971207
ThermoLase Corporation 10455 Pacific Center Court San Diego, CA 92121-4339
SoftLight Q-Switched Nd: YAG Laser
Q-Switched Nd: YAG Laser
Instrument, Surgical, Laser Powered (Laser Surgical instrument for use in General and Plastic Surgery and Dermatology)
ThermoLase SoftLight Q-Switched Nd: YAG Laser. The predicate device is a dermal laser indicated for use in removing or lightening unwanted facial or body hair. The operating wavelength is 1064 nm and is typically operated at a fluence of 2.8 J/cm2.
The SoftLight Q-Switched Nd: YAG Laser Skin Treatment System consists of the laser device and a topical lotion.
The topical lotion is massaged into the skin and absorbs energy from the laser. The interaction between the laser and the lotion results in formation and liberation of mechanical and heat energy sufficient to ablate epidermal skin layers.
The ThermoLase SoftLight laser is indicated for use in combination with a ThermoLase-supplied topical lotion in removing or lightening unwanted facial or body hair. It is also indicated for use with the same lotion for laser skin resurfacing.
{1}------------------------------------------------
ThermoLase Corporation 510(k) Premarket Notification Laser Skin Resurfacing
(Hz) and single shot. The Q-Switched output pulses are nominally 6-20 nsec in duration. The output beam is delivered through a 7 mirror articulated arm and beam delivery handpiece which allows an easy access to the treatment site. The collimated laser beam gives a fixed spot size of between 6 and 7 mm at the treatment site. This laser can be set to deliver fluences of between approximately 1 to 3.5 J/cm2.
The laser energy and repetition rate settings are adjusted and monitored through a microprocessor-controlled key pad on the control panel of the laser. These operating parameters are virtually identical to the operating parameters of the ThermoLase SoftLight O-Switched Nd: YAG Laser System on which substantial equivalence is based.
Topical Lotion The accessory topical lotion is a suspension of carbon powder, in a base of Light Mineral Oil, NF.
Clinical trials involving human subjects followed for 8 months showed no safety issues. The treatment was shown to remove or ablate skin epidermis in the treatment area.
Performance data
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized symbol resembling a bird or abstract human figure, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1998
Mr. Robert van Osdel, R.A.C. Regulatory Affairs Manager ThermoLase Corporation 10455 Pacific Center Court San Diego, California 92121-4339
Re : K971207 Trade Name: SoftLight Q-switched Nd:YAG Laser Regulatory Class: II Product Code: GEX Dated: February 4, 1998 Received: February 12, 1998
Dear Mr. van Osdel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
{3}------------------------------------------------
Page 2 - Mr. van Osdel
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
C. Sue Hickman, Ph.D., M
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K971207 510(k) Number (if known): __
Device Name: SoftLight O-switched Nd: YAG Laser
Indications for Use:
The SoftLight Q-switched Nd: YAG laser is indicated for use in combination with the supplied lotion for skin resurfacing. It is also indicated for the removal or lightening of unwanted facial or body hair.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Puselliz
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971207
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.